Archive for the ‘Government Behaving Badly’ Category

Opioid Use in the Veteran’s Administration System

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Recent news reports have denounced rates of opioid prescribing for war veterans. According to the Center for Investigative Reporting, rates of opioid prescribing by VA doctors have increased two hundred and seventy percent over the last twelve years. The VA is now prescribing more than one opioid prescription for each patient it treats. (1)

The dramatically different opioid prescribing rates between different VA systems are concerning. For example, doctors at a VA hospital in Oklahoma prescribed 160.7 opioid prescriptions for every one hundred patients, compared to doctors at a VA hospital in Manhattan, who prescribed 19.8 opioid prescriptions for every one hundred VA patients treated. That’s more than an eight-fold difference.

Of particular interest, out of the 130 VA systems evaluated, Mountain Home, Tennessee, ranked as the sixth most frequent prescriber of opioids. Located in Johnson City, TN, this VA system had a rate of 138.8 opioid prescriptions per 100 patients for 2012. The worst system was Muskogee, OK, with 160.7 per 100 patients, followed closely by Beckley WV, Lexington, KY, and Huntington, WV. (But remember, Tennessee’s Department of Mental Health said there was no need for an opioid treatment center to be located in Johnson City. Nope. No problem there.)

We already know that in some states, the numbers of U.S. citizens who die from drug overdoses outnumber deaths from motor vehicle accidents. But veterans treated by VA doctors die from prescription drug overdoses at almost twice the rate of civilians. (1)

To be fair, we need to consider the changing nature of war injuries. Soldiers are surviving catastrophic injuries which would have been fatal in the past. This is partly due to better body armor and partly because of better and quicker medical care at the time of the injury. Some experts say some Iraq and Afghanistan soldiers have survived severe burns and amputations that killed Vietnam-era soldiers.

These patients surely need heavy opioids, at least early in their treatment. No compassionate doctor would skimp on pain medication for an acutely injured person. But acute pain is different from chronic pain. As the patient recovers, it’s time to consider backing off on opioids, and consider trials of non-opioid means of pain control. Patients often need help getting off prescribed opioids, which may mean tapering them over weeks to months, in order to prevent opioid withdrawal. This often takes more time and patience than writing another opioid prescription.

Due to the nature of the Iraq and Afghanistan wars, thousands of veterans have been diagnosed with traumatic brain injury (TBI). We are only beginning to understand the relationship between TBI and the risk for developing addiction. Similarly, war veterans have higher rates of PTSD (post-traumatic stress disorder) and depression. These mental disorders increase the risk for developing addiction to drugs including alcohol in all people, including war veterans.

I’ve admitted a few war veterans to the opioid treatment programs where I work. I dread trying to coordinate care with their VA doctors. Many times, after getting a release from the patient, I’ve called the VA to talk with their doctor. I can’t think of one time when I’ve reached the doctor to whom I wanted to speak. Sometimes I got a nurse, and left a message for the doctor to call me back, knowing I’d never hear from them.

I don’t have any way to know what those VA doctors are prescribing for my patients. Often, at least in my area, it’s a heavy benzodiazepine or two, and one or more opioids. Because the VA doesn’t report medication to my state’s prescription monitoring program, I’m left in the dark. I hear that’s supposed to change, but not soon enough for me.

The VA can fix this problem of inappropriate prescribing. I’ve been at ASAM (American Society of Addiction Medicine) conferences, and have met knowledgeable VA physicians. I’ve heard them lecture at these meetings. The VA must allow these experts teach their colleagues who are dated or oblivious in their prescribing habits.

I hope to see the time come when it’s as easy for a war veteran to access treatment for addiction as it is to get opioid prescriptions. These treatments should, of course, include medication-assisted treatments with buprenorphine and methadone.

Our veterans deserve the best care possible.

1. http://cironline.org/node/5261

Heroin Invades New England

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Last week the New York Times ran an article on heroin, describing how it’s infiltrated not only big cities, but also New England’s smaller towns and suburbs. http://www.nytimes.com/2013/07/19/us/heroin-in-new-england-more-abundant-and-deadly.html?pagewanted=all&_r=0
This Colombian heroin has a higher purity than users have seen in the past, meaning it can be snorted for an opioid high. Addicts who wouldn’t consider using a needle are willing to snort this heroin. And addiction being what it is, some of these addicts do eventually inject the drug.

In Maine, New Hampshire, Vermont, and Massachusetts, heroin is causing increased numbers of overdose deaths. Some experts say heroin is now being used by pain pill addicts. Since regulations around opioid prescribing have tightened, fewer (and more expensive) prescription opioid pills are diverted to the black market. Low-priced, high-grade heroin has been released into this void, creating ideal conditions for rampant heroin use. This Times article quoted law enforcement officials as saying they are seeing triple the number of overdose deaths from heroin this year as compared to several years ago.

Wow, I thought when I read the article. This is a bad situation, and it’s been brewing for years. Maine was one of the first states to see a sharp increase in opioid addiction and opioid overdose deaths around ten years ago. So of course, their conscientious state officials did the right thing, and worked together to assure evidence-based addiction treatment would be available for all who ….…oh wait. No.

No, that’s NOT what Maine’s state legislature did. In fact, they did the opposite. Duh.

Last year, Maine passed a law last year limiting Medicaid payment for treatment with methadone or buprenorphine. Against this backdrop of addiction and death, state officials decided to limit payment of treatment to two years of maintenance with either buprenorphine or methadone, and even made it retroactive to the date the patient started. After addiction medicine specialists decried the stupidity, not to mention the illegality of this, government officials backed off somewhat from their two-year limit. But the Maine legislature cut coverage and funding for opioid addiction treatment with buprenorphine and methadone in order to save money.

As I never seem to get tired of repeating: Medication-assisted treatment of opioid addiction with buprenorphine and methadone is one of the most heavily evidenced -based treatment in all of medicine.

Earlier this year, the American Society of Addiction Medicine, better known as ASAM, issued a public policy statement regarding pharmacological therapies for opioid addiction, which can be read in its entirety here: http://asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policy-statements/2013/04/25/pharmacological-therapies-for-opioid-use-disorders

ASAM’s statement says limitation of coverage for opioid addiction will cost lives. It will disrupt families and communities. It warns against limits on duration of treatment, number of times of treatment, and any other limit imposed by non-physicians on the medical care of patients with opioid addiction.

ASAM is a society of the most highly educated and experienced physicians who work in the field of Addiction Medicine. In other words, these are the best brains in the country when it comes to treatment of opioid addiction that exists in our nation. One would think that federal, state, and local governments would pay attention to what they had to say. One would think insurance plans would do the same.

The federal Mental Health Parity and Addiction Equity Act, passed in 2008, was intended to entitle patients with mental illness and substance abuse issues the same medical coverage as patients with other illnesses. Clearly the Act is being violated in Maine and other states, but so far the federal government hasn’t enforced the law.

I rarely advocate for the involvement of lawyers into any situation, as they can complicate the simplest of situations. However, here’s a situation ripe for picking. It’s going to take legal action by patients who have been denied federally mandated medical coverage to get the attention of insurance payers. This is against the law. This includes federal and state coverage as well as private insurance, because all have put some limits on coverage of the treatment of addiction.

It’s important to try to educate state legislators and to let them know you are watching to see if they are doing the right thing. But when they don’t do the right thing, maybe it’s time to call in the lawyers.

Medical Care in Opioid Treatment Programs: Red Tape

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At recent meetings of OTP medical directors in my state, we’ve had renewed discussions about how to provide primary care and psychiatric care to program patients.

Opioid treatment centers that are able to offer a wider array of services than just dosing with methadone show better patient retention in treatment and better patient outcomes. This means that the more services that are added, like psychiatric care, primary medical care, help with employment, and family counseling services, patients in those programs have better outcomes than patients in programs that offer only medication and individual counseling. This shouldn’t be a surprise; it makes sense to me. (1)

The problem is, of course, these extra services cost more to the treatment program. If you want to offer psychiatric services, a psychiatrist must be hired, usually on a contract basis, to be available during dosing hours. If the program’s medical director is a psychiatrist, that doctor has to be paid for the extra time it takes to provide the extra care. More commonly, patients are referred to other places for low-cost psychiatric help.

It’s the same with medical care. In order to offer any level of primary care, you have to hire a doctor, unless patients are asked to pay extra for this. Most patients can barely afford basic treatment, so extra expenses can’t be obtained.

At both of the programs where I work, I used to offer some level of primary and psychiatric care. I used to try to treat uncomplicated mental illness like depression and anxiety disorders, and non-chronic, low-intensity primary care illnesses. Of course I referred patients who needed ongoing medical or psychiatric care, but was able to provide them some level of care until they got an appointment, or were able to afford an appointment. I already knew their history of addiction and didn’t prescribe anything that would interact with methadone or buprenorphine, of course. It didn’t cost the patient anything to see me for these extra services, so it saved patients money. I saw six or seven such patients each time I worked at the clinic, and they didn’t necessarily need any appointment. It seems like a good thing all around.

But then came time for us to have our first CARF survey in one program.

Treatment centers want to be certified by the Commission of the Accreditation of Rehabilitation Facilities (CARF). CARF personnel are invited to facilities for a voluntary inspection. These OTPs hope to be given a sort of seal of approval by this agency. The CARF agency inspects mental health, substance abuse treatment, and physical rehabilitation facilities, as well as youth and family service facilities. Accreditation is important because it demonstrates the facility is providing good care.

Our CARF survey went fair in most regards. We got a one-year accreditation, and the CARF surveyors had good things to say about our clinic regarding our dedication to our mission to help our patients. They said great things about the staff enthusiasm and outlook. But they did not like how I was providing primary physical and mental healthcare. The CARF people supported the idea of providing primary care to patients, but they had many recommendations about how to do it. They wanted implementation of a few policies and procedures. This is what they recommended, verbatim:

F.2.a.(1) through F.2.b.(16)
It is recommended that ongoing documented training and education on medications be provided to the person served, family members, individuals identified by the person served, the team, and service providers. This ongoing training should include how the medication works; risks associated with each medicine; the intended benefits as related to the behavior or symptom targeted by the medication; side effects, contraindications, and potential implications between medications and diet/exercise; risks associated with pregnancy; the importance of taking medications as prescribed, including, when applicable, the identification of potential obstacles to adherence; the need for laboratory monitoring; the rationale for each medication; early signs of relapse related to medication efficacy; signs of nonadherence to medication prescriptions, including alcohol, tobacco, caffeine, illicit drugs, and alternative medications; instructions on self-administration, when applicable; wellness management and recovery planning; and the availability of financial supports and resources to assist the persons served with handling the cost associated with medications.

F.a.(1) through F.4.c.(3)
It is recommended that, when medications are prescribed for or provided to a person served (including those self-administered medications), an up-to-date individual record of all medications, including nonprescription and non-psychoactive medications, include the name of the medication; the dosage; the frequency; instructions for use, including the method/route of administration; and the prescribing professional. The program should provide ready access to the telephone number of a poison control center to the program personnel and the person served. Written procedures that address how the medication will be integrated into the overall plan of the person served should be available. There should be a process for identifying, responding to, documenting, and reporting medication reactions and actions to be followed in case of emergencies related to the use of medication.

F.5.a.through F.5.n.
It is recommended that, as the organization prescribes medications, it implement written procedures that include compliance with all applicable local, state or provincial and federal laws and regulations pertaining to medications and controlled substances, including on-site pharmacy services and dispensing. Written procedures should include the active involvement of the persons served, when able, or their parents or guardians, when appropriate, in making decisions related to the use of medications; the availability of a physician, pharmacist, or qualified professional licensed to prescribe for consultation 24 hours a day, 7 days a week; documentation and reporting of observed and/or reported medication reactions and medication errors; and a review of past medication use, including effectiveness, side effects, and allergies or adverse reactions. Written procedures should include the identification of alcohol, tobacco, and other drug use; use of over-the-counter medications; use of medications by women of childbearing age; use of medications during pregnancy; special dietary needs and restrictions associated with medication use; necessary laboratory studies, tests, or other procedures, when applicable; documented assessment of abnormal involuntary movements at the initiation of treatment and every six months thereafter for persons served receiving typical antipsychotic medications; when possible, coordination with the physician(s) providing primary care needs; and review of medication use activities, including medication errors and drug reactions, as part of the quality monitoring and improvement system.

F.6.a. through F.6.f.
If the organization provides prescribing of medications, it is recommended that it implement written procedures that include screening for common medical co-morbidities using evidence- or consensus-based protocols; evaluation of co-existing medical conditions for potential medications impact; identifying potential drug interactions, including the use of over the counter or homeopathic supplements; documentation or confirmation of informed consent for each medication prescribed, when possible; continuing a prescribed medication if a generic medication is not available; and continuity of medication use, when identified as a need in a transition plan for a person served.

F.7.a.through F.7.b.(2)
It is recommended that, as an organization that provides prescribing of medications, it demonstrate, to the extent possible, the use of treatment guidelines and protocols to promote state-of-the-art prescribing and ensure the safety of the person served. It is also recommended that a program of medication utilization evaluation include measures of effectiveness and satisfaction of the person served.

F.8.a. through F.8.e.(2)
As an organization that provides prescribing of medications, a documented peer review should be conducted at least annually on a representative sample of records of persons for whom prescriptions were provided in order to assess the appropriateness of each medication as determined by the needs and preferences of each person served and the efficacy of the medication. It should be used to determine if the presence of side effects, unusual effects, and contraindications were identified and addressed and if necessary tests were conducted and used to identify the use of multiple simultaneous medications and medication interactions.

F.9.a. through F.9.c.
It is recommended that information collected from the peer review process be reported to applicable staff, used to improve the quality of the services provided, and incorporated into the organization’s performance improvement system.

Huh?
I was overwhelmed. I’m a relatively intelligent person, but I’m still fuzzy on exactly what they mean. Here are some of my concerns:
-I already record a full history and physical on each patient, and have a record of all medications each patient takes. But apparently the way I’m doing this isn’t adequate, and I’m left to wonder what the specifics of their recommendations would look like.
-Get a signed informed consent in order for me to write a prescription? This is not generally done in primary care. Maybe if I were administering chemotherapy…but I was prescribing things like penicillin for an infected tooth. I’m not sure what the justification for this is in a methadone clinic population.
-Apparently I need to give each patient a written summary of all side effects of a prescribed medication. I don’t do this in primary care, because the pharmacy does all of that. Each time a prescription is filled, they give a long sheet of possible side effects. What’s the rationale for redundancy?

When faced with the task of complying with all of these recommendations, the owners of this clinic said forget it. They told me to prescribe only the methadone and buprenorphine, and when I saw other medical problems, provide a referral to doctors in the community. That way, the opioid treatment center won’t be penalized by CARF for not implementing…well, the byzantine recommendations above. I still don’t know exactly what CARF meant. Maybe I should say I don’t know what their recommendations would look like in real life.

Not providing any primary care took pressure off of me, but our patients were left with less medical care than they already have, which is little. It’s really hard to “coordinate care” for patients who have no insurance and no money. Yes, I know there are free clinics available in many areas, but they only provide a limited amount of care and follow-up. And specialty care is unattainable.

At our next CARF survey a year later, our program got good marks from CARF, and a three-year accreditation, instead of only one year. Without requirements around primary care to meet, it was simple.

CARF does a needed service, but in many matters I think it’s important to pull back to see the whole picture. Plus, drop the jargon and use words that make sense, please. It’s similar to the paperwork requirements for Medicaid – most of this paperwork is probably needed in some form or fashion, but I’ve seen the repetition. Leave counselors time to counsel.

Regulations are important. But don’t make the regulations so obscure and onerous that most clinics stop providing any extra care because of the difficulty meeting these requirements.

I’d love to see my state’s methadone authority work with the CARF organization. Maybe together they could issue new guidelines for primary care in opioid treatment programs that make sense. Then programs may be more likely to offer extra services.

(1) McLellan AT, Arndt IO, Metzger DS, Woody GE, O’Brien CP. The effects of psychosocial services in substance abuse treatment. JAMA 1993;269(15):1953-59

FDA Favors More Restrictions on Hydrocodone

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Last week, a panel of experts at the Food and Drug Administration voted in favor of new regulations on prescription pain pills containing hydrocodone. Hydrocodone is the active ingredient in name brand opioid pain relievers like Vicodin and Lortab, which contain mixtures of hydrocodone and acetaminophen. These preparations of hydrocodone are presently Schedule III controlled substances.

Any potentially addicting drug is given a Schedule designation from I through V. Schedule I reserved for drugs with little medical use and very high abuse potential, Schedule II for medications with medical uses but high addicting potential, and so on, down to level V, reserved for medications with slight risk for addiction but with medical uses.

At present, regulations for Schedule II medications like Opana and methadone are more stringent than for Schedule III medications like Vicodin and Lortab. Schedule III medications can be written with refills if the physician decides this is necessary and prudent. Schedule III medications can be called in by telephone, while Schedule II can’t be called in by a physician or anyone else, and even the written prescriptions can’t be refilled. A new prescription must be written by the doctor if a Schedule II pain medication is to be continued.

The New York Times article didn’t explain whether the FDA aims to recommend a change in the schedule designation of hydrocodone, or if new regulations will be put in place in some other way. This matters a great deal, since in some states, only physicians can write for Schedule II medications, and nurse practitioners and physician assistants can’t prescribe them at all.

Any reader of my blog knows I’m in favor of more cautious prescribing of opioids by all providers, because loose prescribing habits are one causative factor in our present epidemic mess of opioid addiction. However, we can over-react to the crisis, to the point of making it unreasonably difficult for patients with acute pain to get reasonable care.

In states where physician extenders like nurse practitioners and physician assistants aren’t allowed to prescribe Schedule II medications, the outcome could be dire. Some communities rely on these providers because there are few physicians in the area. This new decision could make it very difficult to get appropriate pain medication for even short-term use in rural areas with few physicians.

There are dozens of medical situations when it’s handy to be able to call in a refill of hydrocodone when pain extends longer than expected. If refills can’t be called in, doctors and dentists may actually decide to prescribe more pills at a time, knowing they won’t have the luxury of calling in a few more pills.

The New York Times article mentioned nursing home patients as one group who could be adversely affected by the new recommended changes. Many are frail, and unable to travel back and forth to a doctor’s office to get a new prescription each time one is needed for a chronic pain condition. In some areas, doctors come to see the patients at the nursing home facility, though not in all facilities. Home-bound patients with chronic pain would be required to travel to doctors’ offices.

Hydrocodone is the number-one prescribed opioid in our country, and certainly many pain pill addicts have used it illicitly. But by the time addicts come to me for treatment, it’s rare for hydrocodone to be only opioid being abused. Most of the addicts I admit to treatment say they may have started with hydrocodone, but switched to more powerful opioids at some point in their addiction. Perhaps hydrocodone is more of a “gateway” opioid for these addicts.

Restricting access to hydrocodone will likely reduce addiction, because studies do show that decreased access to drugs (including alcohol) decreases the number of people who become addicted. But let’s not overlook the hardships over-regulation may cause to patients with acute pain.

It will be interesting to see what happens if/when these new recommendations take effect.

Closing Down a Methadone Clinic

 

I read the front page article in last week’s Alcoholism and Drug Abuse Weekly with mixed emotions. http://www.alcoholismdrugabuseweekly.com/

The state of Minnesota revoked the license of the only methadone treatment program in the city of Duluth and ordered it to shut down. This order was suspended until the outcome of an appeal by the owners on the clinic, Colonial Management Group.

I felt angry and chagrined.  I support methadone treatment programs, both because they conduct one of the most evidence-based treatment interventions in all of medicine, and because that’s the type of setting where I work. I’ve seen the life changing benefits many patients get from methadone treatment. Closing this clinic would deprive opioid addicts of an effective treatment for their addiction in the city of Duluth, and existing patients would be essentially abandoned.

But bad clinics harm the reputations of good clinics. The list of charges against the clinic is appalling, and if true, couldn’t be ignored. I’d hope that instead of closing the clinic, some other option could be found. CSAT’s Nic Reuter, interviewed for the ADAW piece, said that in extreme cases, a team of professionals could be requested from CSAT, to come to this program and make changes, help turn things around.

I’m also suspicious. A Duluth newspaper had run a weeklong series of articles critical of for-profit methadone clinics just before the order to close was issued. Is this a bad clinic or the victim of a witch hunt? Were the inspectors pressured to find flaws, or were the flaws chronic and egregious?

I’ve worked for one non-profit program with several different clinic sites, and I’ve worked for four for-profit sites. If I graded overall quality of care, I’d rank the non-profit program fourth.  Just because a program is non-profit doesn’t mean it’s well-run, and for-profit clinics often are extremely well-run. From my personal experience, the bias against for-profit programs isn’t justified.

Colonial owns fifty-eight clinics in seventeen states, according to the ADAW article. I’ve never worked at a Colonial clinic, but I do know they’ve had problems in other states.

At one Colonial program near me, I heard from several of their former patients that their clinic once ran short of methadone. According to these two sources, the clinic reduced everyone’s dose until they could procure more methadone. I would die of embarrassment if I worked for a clinic that did such a thing. I would much rather guest dose everyone at a nearby clinic so that the patients didn’t de-stabilize. Guest-dosing would likely cost both clinic and patients extra money, though.

The Colonial programs in my area also allow methadone patients to have prescriptions for benzodiazepines, because I’ve had a few patients transfer for that reason. In my medical opinion, this is prohibitively risky for most patients, though may be appropriate for a limited few.

I’m more suspicious than the average person because I’ve worked at a well-run clinic that was the victim of an apparent witch hunt. I believe the pair of inspectors from the state’s Division of Health Service Regulation arrived with an agenda…to uncover nefarious doings at the methadone clinic. Their routine would have been comedic, if the outcome hadn’t been so awful.

Prior to this encounter, I’ve had positive experiences with the state’s methadone clinic inspectors. They were educated and competent, and often able to suggest ways to do things better and more efficiently, based on what they’ve seen at other clinics. Before I encountered this pair, I viewed inspectors not as adversaries but as potential information resources.

These two were different. They caused one problem after another at the clinic they were inspecting. I wasn’t there, but heard second hand that they interrogated nurses and counselors in an aggressive and demeaning manner. I believe these accounts, because they did the same with me.

After several days spent inspecting and disrupting the clinic, they wanted to talk to me because I was the medical director at that time. First of all, they were an hour and a half late for our appointment, which did not endear me to them. When they finally appeared, their dress and demeanor didn’t inspire confidence that a fair evaluation was about to be done. One of them was openly hostile to methadone maintenance treatment and the other didn’t say anything…but she wore an outfit that could be fittingly accessorized by a lamppost and a public defender, if you get my drift.

The spokeswoman of the two was a nurse – she kept reminding me of that for some reason – who would ask questions along the lines of, “Have you stopped endangering patients yet?” A yes or no answer wasn’t possible. Plus, at first, part of my mind was distracted, marveling at the silent partner’s outfit. I was wondering if I could ever get away with wearing an ensemble like that to work. Probably not, since we couldn’t even wear open-toed shoes…plus, was I a little too long in the tooth to be able to pull it off?….Maybe if I had tattoos like her…

“Why do you let patients keep going up on their dose?” Her aggressive tone snapped me back to attention. “Wouldn’t you agree few people need more than 70mg?” I tried to educate her that best results were seen when patients were at blocking doses, and that 70mg wasn’t a blocking dose for many people. She stared at me over the top of her reading glasses for a long moment. Then she sighed deeply and slowly shook her head side to side as she wrote something on her papers.

Then she said I was providing substandard care by not doing EKGs on patients. This was in 2007, and ironically enough I’d just returned the week before from an ASAM conference where we talked in detail about whether EKGs should be done and under what circumstances. I told her there was no clear consensus yet, but that may become the standard of care. She argued, said no, I was wrong, that was the standard of care now.

She asked why patients with positive drug screens were allowed to remain in treatment. My eyelid started to twitch about them, because it was clear she knew nothing about methadone maintenance treatment, but held a strong bias against it. I told her many patients have positive drug screens, and we see best results by keeping them engaged in treatment. If they’re still using opioids, we actually need to increase their dose, as I described before. And she argued with me about that.

I asked if she’d ever inspected methadone clinic before ours. She said no, but that she was a seasoned state inspector. Hoping to educate her, I asked her if she was familiar with TIP 43, SAMHSA’s published guideline to methadone treatment of opioid addiction. She said no. I jumped up and ratted around in several counselors’ offices, finally finding a copy that wasn’t too dog eared. I gave it to her, hoping she would read it. If she’d read it before trying to inspect a methadone clinic, she’d have known how to do her job better.

The next day, I wrote a complaint letter to her supervisor at the state, describing her objectionable behavior and lack of knowledge. I heard nothing more until a few months later, when a disjointed and rambling report, authored by the nurse inspector, accused my clinic of numerous misdeeds. We were charged with two major level one violations and charged thousands of dollars in fines for substandard care.

Her report was so jumbled that I couldn’t tell specifically what the violations were, but they seemed to focus on a patient in methadone maintenance who had surgery and received post-operative pain pills. Her report said this could have caused a fatality and was substandard care. (So much for my hope that she would read TIP 43!). This patient had actually received great care. Release of information was passed both ways, to and from her methadone clinic. She didn’t relapse on her post-op prescriptions, and had no problems. But this inspector thought she ought not to have been allowed to take opioids post-operatively.

This report was released to local media, and an article based on her report landed on the front page of the city paper. The real facts – that this woman didn’t have the education to be able to know if a clinic was well-run or not – weren’t known to the writer at the paper. Our clinic, coincidently a non-profit, took the case to court. Possibly to avoid a public hearing, the state dropped the level one charges and the fines. The clinic was left with several misdemeanor violations, easily cleared up. Everyone seemed happy but I still object to the misplaced power this woman had. I had looked forward to a public hearing so that flaws of the present system could be exposed and fixed. This inspector had caused harm to our clinic’s reputation.

This year, five years later after that episode, I heard this same inspector, still employed by the state, gave a very negative report of another clinic. The regional director of that clinic described it as an unfair hatchet job, and I have no doubt that’s true. I don’t understand why the state allows such a person to represent them in the field.

So in summary, the Duluth Colonial program may be a bad clinic that should be overhauled and possibly managed by a special team if other treatment options can’t be located for the patients. Or it may have received unfair assessment by someone with a political axe to grind.  Things are not always what they appear to be in the world of medication-assisted treatment.

Inmates with False Positive Drug Tests Accused of Taking Suboxone

According to news reports, inmates in Attica, New York, were wrongly accused of using buprenorphine (generic for the active medication in Suboxone and, Subutex). Apparently their urine drug screening system had a glitch, and nearly fifty inmates had these false positive screens. The prisoners, their lawyers, and their families badgered the Department of Corrections to investigate further, and when they did question the drug testing company, the unexpected results were found to be due to lab error. Until the error was acknowledged, inmates received sanctions and punishments including solitary confinement. It took a little over a month to discover the tests were in error, but at least the error was caught and acknowledged.

This is a good example of the lack of credibility addicts and inmates have. If a known addict protests a positive drug screen, much of the time they’re assumed to be lying. It’s not only law enforcement personnel who think this way; treatment center personnel can begin to believe all addicts are lying when they say their drug test results are wrong.

We must remember that no test is 100% correct and there will be false positives (the test shows drug use where none occurred) and false negatives (drug use occurred but wasn’t detected by the test) on screening tests. Granted, the rates of error are fairly low, but if you do enough tests, some addicts will be falsely accused of using drugs that they didn’t use.

That’s why secondary testing is crucial for contested results.

Most drug testing has two parts. The first screening test is quick, cheap, and relatively accurate. Most of the time, this test is sufficient. But in situations where positive tests have major negative consequences for the person being tested, a second, more accurate (and more expensive) test should be offered.

The second test is usually based on gas chromatography. If chain of custody has been maintained, the results of this test meet the legal standard of “beyond a reasonable doubt.” In other words, while no test is 100%, this test is so close that the courts accept it as proof.

At the opioid treatment programs where I’ve worked, many patients claim that their positive screening tests are in error, and they haven’t used the drug in question. That’s when the second test should be offered. However, gas chromatography is more expensive, and the issue becomes who should pay this extra thirty to forty dollars – the treatment center or the patient?

At one treatment center where I’ve worked, staff tells the patient that the second test will be done if the patient requests, but if the test is confirmed as being a true positive, the patient pays the cost of the second test. If the second test does NOT confirm the questioned result, the treatment program bears the cost. Thus, most people who know they’ve used the drug in question don’t request the second test because it’s a waste of their money. And patients who know they haven’t used are understandably eager to have the second test done on their sample, so they can prove their continued abstinence from drugs.

Drug testing is essential in the treatment of addiction, but treatment centers should make sure their tests are done by a certified lab and interpreted by a trained physician if questions arise. Confirmatory testing should be offered as an option to patients who question screening results.

Tennessee: Epic Fail?

In my last blog, I wrote about information regarding prescription opioids released last fall by the Centers for Disease Control and Prevention. This information gives states’ data for both number of overdose deaths per capita and kilograms of opioids prescribed per capita. Though Tennessee had the 13th highest overdose death rate in the nation, it was the second highest in amount of opioid prescribed per capita, with 11.8 kilograms of opioids prescribed per every 10,000 people.

By the way, North Carolina had a prescription rate of 6.9 kilograms per 10,000. This means that doctors in North Carolina prescribe only around fifty- eight percent of what doctors in Tennessee do, adjusted for population.

We know that areas with more prescribed opioids have higher addiction and overdose death rates than areas with lower rates of prescribed opioids. That’s clear not only from the CDC data, but also with what we know from other studies of addictive drugs.  Any time an addictive substance is more available, more people become addicted. This holds true from prescribed medication just as it does for illicit drugs and alcohol. Just from the CDC data alone, it seems apparent that Tennessee has a big problem with pain pill addiction.

Now let’s look at the treatment options for opioid addicts. The best treatment outcomes for opioid addicts are consistently seen with medication assisted treatment with buprenorphine (Suboxone) or methadone.

Other treatment approaches can work, such as medical detoxification followed by at least one month of inpatient residential drug addiction treatment. Better results are seen with longer residential treatments, but inpatient options are often not attainable from the working poor, who are uninsured or underinsured. Therapeutic communities, where the addict lives and works in a community of recovering people, and also receives addiction counseling, can work for those people who can take eighteen months out of their lives for treatment.

And we know what doesn’t work. Putting addicts in jail doesn’t work. If it did, we would have been curing addiction since the 1950’s, when incarceration was first put forward as a solution to the addiction problem.

Inpatient detoxification alone does not work. Relapse rates for opioid addicts, in study after study, are consistently in the 90 to 96% range, and most of these relapses are within the first month. Yet in many communities, the same addicts are cycled in and out of detox, and then blamed because they couldn’t stay clean, even though we know they had less than a 10% chance of being successful.

Medication-assisted treatment with buprenorphine and methadone work well, and work quickly. These approaches are more acceptable to the addicts, and much more affordable, at least in the short-term. We know such treatment saves lives, reduces drug overdose deaths, reduces infectious diseases like HIV, reduces suicides, reduces crime, and improves overall physical and mental health.

But Tennessee has only ten opioid addiction treatment programs in the entire state to serve its present population of 6.3 million. And remember these folks have almost twice the opioids than their North Carolina neighbors. North Carolina, with a population of 9.5 million people, has forty-five opioid addiction treatment programs, ready to treat opioid addicts with the best evidence-based treatment available.

Using present estimates of the numbers of opioid addicts who need treatment, even North Carolina doesn’t have enough space in their opioid treatment programs to treat them all. But then, not all of the addicts want help. Tennessee doesn’t even come close to having adequate, evidence-based treatment available for its citizens who become addicted to pain pills. Thankfully, Tennessee does have buprenorphine (Suboxone) doctors, and the http://buprenorphine.samhsa.gov website lists 292 of them. But each doctor can have only up to either 30 or 100 patients per doctor.

Why has this state, which obviously has one of the worst prescription opioid addiction problems in the entire nation, consistently opposed evidence-based treatment for opioid addiction? Sadly, it’s probably the usual culprit: stigma. Even the officials at Tennessee’s department of health and human services must not be educated and informed about which treatments work the best for opioid addicted people.

If I lived in TN, I’d be fighting mad. Actually, I’m already angry, because I see desperate Tennessee pain pill addicts driving from Tennessee to North Carolina for help. I work at a clinic in the mountains of North Carolina, and see patients driving an hour or more to get the help that should be available to them in their home state. I don’t mind. I’m glad to see them, and glad to help them. Almost without fail, they’re really nice people, the kind you’d enjoy having as a neighbor. But too many times I see these people have to leave a treatment that’s working for them because they can’t practically travel that far every day to get their dose of medication.

If I lived in Tennessee, I’d demand that my state officials get their heads out of the sand, and do something to bring their raging pain pill addiction epidemic under control. I’d write the governor, senators, and state representatives. I’d ask why Tennessee’s Division of Alcohol and Drug Abuse Services appears to be indifferent to perhaps the biggest public health issue of our times. If I didn’t get satisfactory answers, I’d be sure to remember and vote accordingly in the next election. Nothing gets a politician’s attention like threatening not going to vote for them.

I might make some noise at a local level, and ask local officials why their communities have refused to allow treatment centers in a state that desperately needs them. Maybe I’d try to organize a group of concerned citizens at the grassroots level. Perhaps larger national organizations like NAMA (National Alliance for Medication-assisted Recovery) could assist.  You can find them at http://www.methadone.org/  And if you go to that website, you’ll find that Tennessee is their number one most important issue, because of the non-evidence-based proposed new regulations on existing opioid treatment programs. NAMA’s website has an address for concerned Tennessee citizens to send mail protesting the proposed regulations. You could also voice your opinion about the need for more treatment centers to help addicts.

But we know treatment centers will never be the whole answer to the problem of addiction. Tennessee, like other states, will need a variety of efforts to solve their problem.

A comprehensive solution will involve things like:

  • Better physician education in medical school, residency, and private practice about addiction and its treatment. Doctors need to know how to prescribe opioids more safely, with proper monitoring. State medical boards need to be clear about prevailing standards for prescribing such medications.
  • Physicians need to make use of important tools like prescription monitoring programs.
  • Drug courts need to be expanded, and need to accept patients on medication-assisted treatments.
  • Citizens need to realize they should not share medications with friends and family, both because it could be harmful and because it’s against the law.
  • Legal action against pill mills. To determine if a pain practice is legitimate or not, allow other physicians to review charts. Other physicians are better trained to do this than law enforcement.
  • Citizens need to make sure all medication is stored securely and out of the reach of children and even adolescents, who often get medications from the adults in their lives.

Consider letting your Tennessee officials know what you think of the job they’ve been doing

Officially an Epidemic

 

It’s official. Prescription drug abuse in the U.S. is now called an epidemic by the Centers for Disease Control and Prevention. In November, CDC officials released a new report of prescription drug addiction. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm?s_cid=mm6043a4_w

It’s really interesting reading.

The CDC points out that prescription opioid overdose deaths now outnumber heroin and cocaine overdose deaths combined and prescription opioids were involved in 74% of all prescription drug overdose deaths.

The breakdown of their data by state is particularly interesting. The states with the highest rates of opioid overdose deaths are, in descending order: New Mexico, with a rate of 27 deaths per 100,000 people, then West Virginia, Nevada, Utah, Alaska, Kentucky, Rhode Island, Florida, Oklahoma, and Ohio. Tennessee missed the top ten, but was still 13th highest in overdose deaths, with a rate of 14.8. North Carolina’s rate was 12.9 per 100,000 people, which put North Carolina 24th out of 50 for prescription overdose deaths. That’s too high, but much improved since 2005, when North Carolina was in the top five states for prescription opioid overdose deaths. The lowest opioid overdose death rate was seen in Nebraska, with 5.5 deaths per 100,000 people.

The CDC also analyzed information about the amount of opioids prescribed in each state. They measured kilograms of opioid pain relievers prescribed per 10,000 people in each state. The state with the highest rate had over three times the rate of the state with the lowest rate. It’s no surprise that Florida had the highest amount, at 12.6 kilograms per every 10,000. Illinois had the lowest amount, at 3.7 kilograms per 10,000 people.

The big surprise: Tennessee has the second highest amount of opioids prescribed, adjusted by population. (OK, they tied for second place with Oregon). Yep. Tennessee, the state that refuses to allow more opioid treatment centers to be built within its borders, has 11.8 kilograms of opioids prescribed per every 10,000 people.  But since I want to devote an entire blog entry to Tennessee’s backward outlook on addiction and its treatment, I’ll defer further comments about that state.

Sales of prescription opioid quadrupled from 1999 to 2010. According to the CDC, enough opioids were sold last year to provide a month of hydrocodone, dosed 5mg every four hours, for each adult in the U.S.

The CDC estimates that for every prescription overdose death, there are at least 130 more people who are addicted or abuse these medications, and 825 who are “nonmedical users” of opioids. (I’m still not sure how nonmedical users differ from abusers. To me, if it’s nonmedical, that’s abuse.) Not all of the 825 are addicted or will become addicted – but they are certainly at risk.

Just like what was found in other studies, people who abuse opioids are most likely to get them for free from a friend or relative. So if you are giving pain pills to your friends or family members, you are part of this large problem.

In 2008, 36,450 people died from prescription overdose deaths. That was nearly equal to the number of people who died in auto accidents, at 39,973. In fact, in seventeen states, the number of overdose deaths did exceed auto accident deaths.

The CDC authors conclude that the prescription opioid addiction isn’t getting any better, and in measurable ways, it’s worsened, with some states worse than others. The worst areas, not surprisingly, have higher rates of opioid prescribing that can’t be explained by differences in the population. To me, this means doctors in some states are overprescribing, or at least aren’t taking proper precautions when they do prescribe opioids.

In my next blog entry, I’ll explain how people and organizations in North Carolina have been working hard to deal with the prescription pain pill addiction problem. Based on information from the CDC, it appears my state has made some major progress, at least compared to one of our neighboring states.

New Controls on Opioid Prescribing

As discussed in my last blog entry, prescription monitoring programs will help diminish our present-day epidemic of prescription opioid addiction, but these PMPs are just a start. State and federal governments are passing other laws, with the intent to reduce pain pill addiction.

For example, over the summer, Ohio enacted legislation aimed at physicians who primarily see patients prescribed opioids for chronic pain. Doctors prescribing opioids for more than 50% of their patients are now required to take periodic continuing medical education classes about the safe prescribing of opioids. These physicians are required to take a minimum of twenty hours of training every two years. Ohio also now says that physicians who own pain practices need to register with their medical board and undergo site inspections, as well as comply with patient-tracking requirements. Six other states now mandate doctors get yearly continuing education on pain management and the safe prescribing of opioids to maintain licensure from their medical boards.

Some doctors protest these measures, but this training is intensely needed. More than ten years ago, CASA (Center on Addiction and Substance Abuse at Columbia University) did a study that showed physicians are poorly trained to recognize and treat addictive disorders. Of doctors who were surveyed about the training they received in their residency programs, thirty-nine percent received training on how to identify drug diversion, and sixty-one percent received training on identifying prescription drug addiction. Seventy percent of the doctors surveyed said they received instruction on how to prescribe controlled substances. (1)

These findings are appalling. Thirty percent of doctors received no training on how to prescribe controlled substances in their residency programs.  Nearly a third of the doctors leaving residency – last stop for most doctors before being loosed upon the populace to practice medicine with little to no oversight – had no training on how to prescribe these potentially dangerous drugs. Sixty-two percent leaving residency had training on pain management. This means the remaining thirty-eight percent had no training on the treatment of pain.

 These doctors weren’t in specialty care. They were in family practice, internal medicine, OB/GYN, psychiatry, and orthopedic surgery. The study included physicians of all ages (fifty-three percent were under age fifty), all races (though a majority at seventy-five percent were white, three other races were represented), and all types of locations (thirty-seven percent urban, thirty percent suburban, with the remainder small towns or rural areas). This study shows that medical training in the U.S. does not, at present, do a good job of teaching doctors about two diseases that causes much disability and suffering: pain and addiction.

 Despite having relatively little training in indentifying and treating prescription pill addiction, physicians tend to be overly confident in their abilities to detect such addictions. CASA found that eighty percent of the surveyed physicians felt they were qualified to identify both drug abuse and addiction. However, in a 1998 CASA study, Under the Rug: Substance Abuse and the Mature Woman, physicians were given a case history of a 68 year old woman, with symptoms of prescription drug addiction. Only one percent of the surveyed physicians presented substance abuse as a possible diagnosis.  In a similar study, when presented with a case history suggestive of an addictive disorder, only six percent of primary care physicians listed substance abuse as a possible diagnosis. (2)

Besides being poorly educated about treatments for patients with addiction, most doctors aren’t comfortable having frank discussions about a patient’s drug misuse or addiction. Most physicians fear they will provoke anger or shame in their patients. Physicians may feel disgust with addicted patients and find them unpleasant, demanding, or even frightening. Conversely, doctors can feel too embarrassed to ask seemingly “nice” people about addiction. In a CASA study titled, Missed Opportunity, forty-seven percent of physicians in primary care said it was difficult to discuss prescription drug addiction and abuse with their patients for whom they had prescribed such drugs.

From this data, it’s clear physicians are poorly educated about the disease of addiction, as well as the safe treatment of pain. Medical schools and residencies need to critically re-evaluate their teaching priorities to include training in pain management and addiction. Until that can be done, states need to mandate yearly training for physicians on these topics, because most practicing physicians never got adequate training on these topics.

Most doctors are not happy about these government mandates. It’s human nature to resent being told you need more training, especially if it’s at your own expense. It’s difficult to get time off work for trainings and it’s inconvenient. Yet the alternative – no increase in training for practicing physicians – isn’t acceptable. The addiction rate is too high in this country to ignore, or to avoid taking actions.

Not all of the new state mandates are good ideas.

The state of Washington passed a law in 2010 that took effect in July of this year. It says only pain management specialists can prescribe more than the equivalent of 120mg of morphine per day for a patient. Non-pain management doctors cannot prescribe more than this, by law.

I think it’s alarming when lawmakers set dose limits for any medication. I don’t know of any other medication in any other state that has a dose limit set by non-physicians.

I assume Washington’s lawmakers had good intentions. They’re concerned about the rising numbers of opioid overdose deaths in their state. They based the cut-off of 120mg of morphine on a study (Annals of Internal Medicine, Jan 19, 2010) that showed patients taking more than 100mg of morphine, or its equivalent, were nine times more likely to have a drug overdose than those prescribe 20mg or less. But these lawmakers aren’t equipped to understand the real life complications that may occur due to this law. Government officials have already admitted they don’t know how patients will be able afford to see pain specialists, or even be able to find a specialist, since there aren’t enough pain specialists in that state. The government’s website explaining the new rules (3) also admits there are no lists of physicians pain specialists. I couldn’t find the state’s definition of a “pain specialist” on this website, so there will be confusion as to what this even means. If it means only doctors who are board-certified in pain management, that will surely be a very small number. Some doctors have said they will avoid prescribing opioids at all, given the additional regulatory burdens.

Other critics of this new law say it gives false gives reassurances to patients and doctors that doses under the 120mg cutoff are safe. We know that’s not true. Many times the danger lies in other medications, like benzodiazepines, that are prescribed with opioids.

This same law goes into great detail about how pain patients are to be screened before opioids for chronic pain are started, and how patients who are prescribed opioids are to be managed. Patients must be screened for past addiction, and for depression and anxiety disorders. The law outlines how patients are to be followed by their doctors. Washington’s lawmakers also mandate random urine drug screening of patients being prescribed opioids, and written patient agreements. The law gets in to specific details about what needs to be in the patient monitoring agreement.

Some doctors feel the government has overstepped its bounds and will interfere with physicians’ clinical judgments. Patients are already complaining that they have great difficulty finding doctors who will prescribe opioids to adequately treat their pain.

I support most legislation that helps physicians identify and treat opioid addiction, but I think Washington’s law has gone too far. Balanced, rational decisions are urgently needed. If we over-react out of fear, the pendulum will swing too far to the other side. Over-regulation could have unintended consequences including having patient in acute or pain or with cancer pain unable to get an adequate prescription for opioids.

  1. 1. Missed Opportunity: A National Survey of Primary Care Physicians and Patients on Substance Abuse, Center on Addiction and Substance Abuse at Columbia University, April 2000. Also available online at http://www.casacolumbia.org  
  2.  Under the Rug: Substance Abuse and the Mature Woman, Center on Addiction and Substance Abuse at Columbia University, 1998. Available online at http://www.casacolumbia.org
  3.  http://www.doh.wa.gov/hsqa/Professions/PainManagement/

A Bit of History

             In the 1980’s, President Ronald Reagan helped guide the thinking of the nation, and emphasized law enforcement as the solution to the war on drugs. The War on Drugs was born. Spending increased for police and other enforcement agencies, but decreased for addiction research and addiction treatment. When crack cocaine captured the attention of America in the mid-1980’s, it re-ignited old fears.

            As in times past, what people thought of drug addicts depended in part on who was addicted. There was much rhetoric about the nature of crime committed by minorities, addicted to drugs, and of crack babies, based more on media exaggeration than on science. As a result, the drug laws were again re-written.

          During the Reagan years, laws were passed that were quite similar to the draconian Boggs Act of the 1950’s. The death penalty was even re-introduced for drug dealers, under certain circumstances. Laws mandating sentences for simple possession were resurrected, and in general, drug laws were set back to the way they were thirty years prior.

            Parents of the 1980s observed with alarm the rise in cocaine abuse, with its hazards and easy availability. They leapt into action, by forming the Parent’s Movement.  They were a powerful political voice that helped coerce lawmakers into passing tougher drug laws. The American public had once again demanded more punitive drug laws.

             Laws passed against the possession of crack were different from those for powder cocaine. The penalty for five grams of crack was the same as the penalty for five hundred grams of powder cocaine. African Americans, of lower socioeconomic status, tended to use crack because it was cheaper than powder cocaine. Therefore, African Americans were more likely than whites to receive a mandatory sentence for drug possession, because it took so little crack, a hundred-fold less, to carry the same sentence. (1)

             State and federal laws differed considerably, because federal convictions could not, by new law, be shortened by more than fifteen percent. This meant that being convicted in federal court lead to longer sentences than being convicted in state courts. District attorneys had the power to decide in which jurisdiction to try an offender, and this gave them considerable influence over the fates of arrestees. Predictably, prisons filled around the country, and prison censuses doubled, at both state and federal levels. (1)

             Shortly before the first of the George Bushes took office in 1989, the 1988 Anti-Drug Abuse Act was passed, which re-organized the bureaucracies assigned to overseeing the drug addiction problems of the nation. Under this Act, the Office of National Drug Control Policy (ONDCP) was formed, and William Bennett was designated drug czar. This agency was given the task of monitoring all of the anti-drug programs in government agencies. The forerunner to the Center for Substance Abuse Prevention (CSAP) was formed in the Substance Abuse and Mental Health Services Administration (SAMHSA). There was much fanfare about new policies, which would both emphasize a zero tolerance toward drug use and also give more attention to treating addiction. However, Bennett resigned abruptly and the fanfare fizzled.

              When Clinton took office in 1993, he cut funding for the ONDCP by eighty-three percent, and exhibited a general lack of interest in addiction and its treatment. His Surgeon General, Jocelyn Elders, angered many when she appeared to advocate legalization of drugs. (2) Probably in response to public pressures, and concerns about the rising rate of marijuana use among adolescents, Clinton publically announced a new attack on drugs, just before the next election year, and nominated Barry McCaffery to head the revived ONDCP.

              Throughout the 1990’s, heroin purity on the U.S. streets was gradually increasing. In 1991, heroin was about twenty-seven percent pure, while by 1994, it had risen to forty percent. That was a dramatic increase in purity, compared to 1970’s and 1980s, when an average purity of three to ten percent was found in U.S. cities. Many potential addicts, scared off cocaine by high profile deaths of people like Len Bias and John Belushi, turned to experimentation with heroin. (1). Columbian drug cartels, diversifying from dealing only with cocaine, began selling heroin to meet an increasing demand by the U.S. Because heroin was so pure, it could be snorted, rather than injected, and many people who balked at injecting a drug would snort it, and did. By 1997, heroin accounted for more treatment center admissions than did cocaine. (2). “Heroin chic”, a trend of thin and ill-looking models as the ideal of beauty, came into vogue in the mid-1990s.

             At that same time, in the mid-1990s, several more ingredients besides higher potency heroin were thrown into the simmering caldron of opioid addiction: the pain management movement and access to controlled substances over the internet. Then, with the release and deceptive marketing of OxyContin, the cauldron began to boil. 

1. David Musto, The American Disease: Origins of Narcotic Control, 3rd ed., (New York: Oxford University Press, 1999) p 274.

2. David T. Courtwright, Dark Paradise: A History of Opiate Addiction in American, (Cambridge, Massachusetts, Harvard University Press, 2001) pp180-181.

excerpt from “Pain Pill Addiction: Prescription for Hope”